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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinicaldevelopment platforms to streamline operations.
The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinicaldevelopment? A recent draft from the FDA provides valuable insight.
NIEL, BELGIUM, eTheRNA Manufacturing, a specialist RNA process developer and manufacturing member of the Belgian eTheRNA group, is introducing a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early pre-clinicaldevelopment of RNA-based therapeutics and vaccines.
The therapy showed that it can inhibit the production of cytokine from both CD4+ T cells and ILC2, and completely suppressed skin allergic reactions in a monkey model in pre-clinical trials. A new recombinant fully human immunoglobulin G1 monoclonal antibody, UPB-101, is now being evaluated in a Phase 1b trial to treat asthma.
Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.
This episode features an interview with Dr. Stephanie Manson Brown, VP & Head of ClinicalDevelopment & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine.
Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinicaldevelopment through Phase Ib for HB-700 to treat KRAS-mutated cancers.
They discussed the value of disease progression modeling an d identified key areas that need to be addressed to incorporate DPM approaches more effectively in medical productdevelopment and regulatory decision-making.
Sutro will oversee the research and preclinical research to detect candidate compounds and subsequently Astellas will carry out the clinicaldevelopment. As per the deal, Sutro is eligible to get $90m in upfront cash payment for developing iADCs for three biological targets.
Rilzabrutinib joins a wave of innovative ITP therapies , including thrombopoietin-receptor agonists like eltrombopag and romiplostim, which boost platelet production. By inhibiting this protein, the drug disrupts pathways that contribute to platelet destruction and insufficient production.
The agreement allows Ablaze to clinicallydevelop and commercialise the drug in Greater China. It is based on RayzeBio’s specialisation in targeted radiotherapy (TRT) discovery and Ablaze’s know-how in therapeutic productclinicaldevelopment, as well as on the radiopharmaceutical infrastructure in China.
Highlights include expansion of biotech operations in Philadelphia, acquisition of a new pharma-device facility near Dublin, Ireland, and a new Center of Excellence for advanced drug delivery and drug-device combination product assembly in Rockford, Illinois.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. It serves various markets including medical clinics and hospitals, pharmaceuticals, health information systems, dental and orthodontic practitioners.
Influenza vaccine 2 is under clinicaldevelopment by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. It serves various markets including medical clinics and hospitals, pharmaceuticals, health information systems, dental and orthodontic practitioners.
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma.
They will also have the potential to treat diseases that are caused by too little protein by increasing production, thus restoring the protein to normal levels. The company will also be entitled to receive potential development and regulatory milestone payments, along with royalty payments.
The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.
BSI, sat down with Liza Laws, the senior editor of OSP and BPR to discuss his companyâs pioneering work in revolutionizing vaccine adjuvant production. During DCAT this year, Gaston Saperi from Botanical Solutions Inc.,
Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Eliminate waste by carefully reviewing all tasks and removing any that are superfluous, optimizing workflows and boosting overall productivity.
on meeting clinicaldevelopment and commercial milestones in the future, in addition to tiered royalty payments, upon the marketing of the product. This includes an upfront payment of $2m from AstraZeneca. Additionally, AstraZeneca will make a potential payment of $385.8m
Myeloid Therapeutics has raised $73m to support the continued clinicaldevelopment of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Myeloid CEO Daniel Getts said: “Myeloid continues to make significant progress across all aspects of our business. “We
The US contract development and manufacturing organization (CDMO) Agno Pharma has taken over compatriot firm Lubrizol Particle Sciences to increase its drug product formulation offerings.
Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies. Presumably, the difference reflects an anticipated higher volume of regulatory submissions from developers of cell and gene therapies, compared to conventional drug products.
Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinicaldevelopment. Enveda Biosciences intends to use the additional financing to advance several candidates derived from its drug discovery platform to clinicaldevelopment in 2023 and 2024.
In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinicaldevelopment.
The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions. Japan, and China.
In vivo and in vitro pre-clinical studies demonstrated that CFT8919 provides wider coverage of on-target resistant mutations and intracranial activity, indicating its potential to be effective against brain metastases. Betta will be responsible for the development, manufacture and commercialisation of CFT8919 in the licensed territories.
“After more than a decade of research and clinicaldevelopment, and through the perseverance of clinicians, patients and their families, the approval of Zynteglo marks a watershed moment for the field of gene therapy.”.
These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. This merger aimed to create a broader and more diversified product portfolio in medical devices and therapies. billion in 2021.
government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinicaldevelopment. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. The decentralized procedure applies to all products without a prior marketing authorization in the EU that are not required to use the centralized procedure.
The China National Medical Products Administration (NMPA) has granted clearance for Ascletis Pharma’s Investigational New Drug (IND) application of its drug candidate, ASC10, for Covid-19. Currently, the company is working with various regulatory agencies to explore the potential to further advance ASC10’s clinicaldevelopment.
Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs.
KFA-115 is under clinicaldevelopment by Novartis and currently in Phase I for Melanoma. Novartis overview Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.
ViXome is an acellular product derived from amniotic fluid. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects. We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”
The new deal, which does not include any initial consideration, will see FibroGen conducting and financing new research, development and production of FOR46 and PET46. FOR46 is a natural fit with our research and development capabilities and expertise.
Jeff Emmick, MD, PhD, senior vice president, productdevelopment, Lilly said, “These results underscore the critical role of long-term therapy with effective treatments like tirzepatide to achieve and maintain weight reduction.”
When developing a clinicaldevelopment program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.
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